MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S603
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a recent follow-up visit to check the battery status of this device, end of life (eol) was reached.Approximately 3 months prior, the battery longevity showed under 6 months remaining.It was noted that there had been no programming changes were made between the most recent follow-up visits.It was also noted that earlier this year, the battery showed less than 0.5 years remaining, with a magnet rate of 90 pulses per minute (ppm).Technical services explained device behavior, and discussed that it will go to 90 ppm about a year prior to declaring elective replacement time (eri).From eri to eol, there is a 90 day timer, so the device most likely declared eri shortly have the device was interrogated a few months prior.The health care provided stated that the patient is not pacer dependent.Subsequently, this device was explanted and replaced.This device had been implanted for nearly 12 years, having exceeded the projected longevity expectations.A good faith effort will be submitted to the field to obtain additional information regarding this device.
Additional Manufacturer Narrative
The returned altrua device was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
It was reported that during a recent follow-up visit to check the battery status of this device, end of life (eol) was reached.Approximately 3 months prior, the battery longevity showed under 6 months remaining.It was noted that there had been no programming changes were made between the most recent follow-up visits.It was also noted that earlier this year, the battery showed less than 0.5 years remaining, with a magnet rate of 90 pulses per minute (ppm).Technical services explained device behavior, and discussed that it will go to 90 ppm about a year prior to declaring elective replacement time (eri).From eri to eol, there is a 90 day timer, so the device most likely declared eri shortly have the device was interrogated a few months prior.The health care provided stated that the patient is not pacer dependent.Subsequently, this device was explanted and replaced.This device had been implanted for nearly 12 years, having exceeded the projected longevity expectations.This device was received for analysis.

• Brand Name: ALTRUA 60
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12661449
• Report Number: 2124215-2021-29711
• Device Sequence Number: 4713327
• Product Code: LWP
• UDI-Device Identifier: 00802526484483
• UDI-Public: 00802526484483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/12/2011
• Device Model Number: S603
• Device Catalogue Number: S603
• Device Lot Number: 137578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male